Compliance Management Featured Articles

11. Incorporating Lean Principles Into Pharmaceutical QC Laboratory Design

    This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. By Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka

12. Calibration Risk Assessment: Where Do You Start?

    I have a question about Risk Assessment analyses for product impact from sensing instruments that have gone out of calibration, specifically in GxP-compliant applications.
    
    Do you have any recommendations on books, training courses, or other resources for managing this?